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From 27 November 2018, the Drug Supply Chain Security Act (DSCSA) will be actively enforced by regulators in the US.

Roundtable questions
In November 2017, the pharma industry was granted an extension of the Drug Supply Chain Security Act (DSCSA) enforcement date to November 2018. Regulators told the market that they would not actively enforce the new serialization requirements until this date.

Thierry Protas, Global Pharma Director at Videojet Technologies, looks at the importance of the Drug Supply Chain Security Act (DSCSA) legislation, the looming 2018 cut off point for compliance, and how coding and marking is a key consideration.

Standfirst:There is growing awareness of the valuable role that diagnostics can play, both in the early identification and treatment of dangerous or infectious diseases as well as genetic disorders.

Compliance is a serious issue for India’s pharmaceutical manufacturers, distributors, and retailers; due to the complicated nature of the pharmaceutical supply chain. Serialization requires pharmaceutical manufacturers to invest in new technology and adapt their current processes and systems.

What is a biosimilar?
Whereas generic drugs are identical copycats of small-molecule chemical products, biosimilars are only similar to biologic products; innately more complex than chemical products, biologics are large-molecule, organic drugs, subject to natural variability and vulnerability due to climate changes during the manufacturing process, and as such, it is impossible to produce an exact replica of a biologic—hence the adoption of the nomenclature, “biosimilar.”

News & Press Releases

Lonza announced the appointment of Allen Burgenson, Global Subject Matter Expert for Endotoxin Detection at Lonza, as Chair of the Horseshoe Crab Advisory Panel of the Atlantic States Marine Fisheries Commission (ASMFC).

Frost & Sullivan has presented INTEGRA Biosciences with the ‘2018 Global Laboratory Pipetting Company of the Year’ award, recognizing its products as innovative, revolutionary and able to fulfil the needs of customers.

Clinerion’s move to new headquarters is driven by growth in its business and its team, and matches the expansion in its international network of partner hospitals.

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, has launched a new virtual customised training service to tackle critical gaps in industry manufacturing software and process training.

Lonza announced that the recombinant Factor C Assay has been used for endotoxin testing of Eli Lilly’s Emgality™ , the first drug approved by the U.S. FDA to have been released using this method instead of traditional Limulus Amebocyte Lysate (LAL) - based methods. Emgality™ is a monoclonal antibody drug treatment for the prevention of migraine in adults.

bioLIVE – the bioprocessing and manufacturing event running adjacent to CPhI Worldwide – will next year incorporate BioProduction Congress to become bioLIVE at CPhI Worldwide.

Medigene AG announced that it has entered into an exclusive license agreement with Leiden University Medical Center, the Netherlands, for worldwide rights to develop, manufacture, and commercialize an HA-1-specific T cell receptor (TCR) as a targeted immunotherapy for cancer.

RetiPharma, focusing on the development of products for the treatment of degenerative eye disorders based on an in vivo platform for translation from in vivo models to humans, is pleased to announce that it has secured funding from the Novo Nordisk Foundation’s BioInnovation Institute (BII).

Sygnature Discovery, a leading independent integrated drug discovery and pre-clinical services company, has announced a multi-target, integrated drug discovery collaboration with Sitryx Therapeutics, a biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation.

Pharm-Olam, a global, midsized CRO offering full-service clinical development solutions for oncology, infectious diseases and vaccines, and rare and orphan diseases, extends its congratulations to Ablynx, a Sanofi company, for its launch of Cablivi® (caplacizumab) in the German market for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

REGENXBIO Inc.  a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, announced updated results from the ongoing Phase I study of RGX-314 for the treatment of wet age-related macular degeneration.

Quotient Sciences, a leading drug development services organization, announces a significant expansion to its operations in the U.S. with the opening of a state-of-the-art, 45,000-square-foot facility located near Philadelphia, in Garnet Valley, Pa.

Recro Gainesville has added a 24,000-square-foot facility, which includes high-potent material processing space, near its existing 97,000-square-foot contract pharmaceutical development and manufacturing plant.

Sirio Pharma Co. Ltd (SIRIO) – the global nutraceutical contract development and manufacturing organization (CDMO) announces the opening of a gummy production plant at its new development and manufacturing facility in Ma’anshan (300km West of Shanghai, China).

Multisorb, the leading provider of oxygen and moisture management technologies, announced the inauguration of a new manufacturing facility in Hyderabad, India.

They’ve extended their industry leading position for product security for global medicines with significant Serialization and Anticounterfeiting technology investment.

ALLpaQ has announced a new partnership with ESI Technologies. This agreement will position ESI as distributor of ALLpaQ’s bioprocess tote and single-use technology solutions in Ireland, UK and the Benelux.

Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to share that temperature-controlled packaging suppliers Cold Chain Technologies and Almac Clinical Services were recently announced as winners of the “Global Forum Excellence Awards for Best Innovative Supply Chain Strategy” and “Best Supplier Collaboration” at the 16th Annual Cold Chain Global Forum in Philadelphia, PA.

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